Ethics issues in U of M psychiatric studies: What does it take to get Regents' attention?

On May 9, a group of students, faculty members and concerned community members held a vigil in remembrance of Dan Markingson outside the McNamara Alumni Center, where the Board of Regents was meeting. Four students wearing white coats carried a coffin to the door of the meeting room, where they were stopped by campus security guards.

On April 29, former Minnesota Gov. Arne Carlson wrote to the University of Minnesota’s Board of Regents [PDF] with two simple questions: How many research subjects have died or been seriously injured in psychiatric studies at the university? And what were the circumstances of those deaths and injuries?

These are urgent questions. Carlson’s letter was prompted by the gruesome May 2004 suicide of Dan Markingson, a mentally ill young man who was pressured into one of the university’s pharma-sponsored drug studies despite the desperate objections of his mother. Markingson’s body was discovered in the blood-soaked bathroom of a halfway house after he tried to decapitate himself.

Last week, KMSP News aired the story of yet another mentally ill man whose harrowing story mirrors that of Dan Markingson. The report said the man, identified as Robert, felt coerced to enroll in a trial of an unapproved antipsychotic drug. “I was incompetent and didn’t know what I was doing,” he told the KMSP reporter. "Then, they say you have a giant medical bill and if you do the research, you won't have this giant medical bill."

He said he was told the unapproved drug was safe, yet the FDA soon rejected the drug, asking the sponsor to look into the death of a research subject who had died of liver failure shortly after taking the drug. Several months later, the sponsor halted all studies.

Severe side-effects

Robert said the side-effects of the drug were so severe he considered suicide. He went to the Fairview emergency room three times, once by ambulance, yet the researcher in charge of the study dismissed his symptoms as “psychosomatic.”

These reports would be alarming if they occurred anywhere. But the Department of Psychiatry's history includes incidences of unethical research. In 2000 the FDA “disqualified” a university psychiatrist in 2000 from ever doing research again after he recruited unwitting Hmong opium addicts into a trial of a powerful, potentially dangerous CNS depressant called GHB. A year earlier, the FDA disqualified a child psychiatrist in the department for research fraud. He was also sentenced to federal prison after a nearly four-year cover-up by the university in which the dean of the Medical School signed a written agreement to keep the fraud secret.

In 1997 the state Board of Medical Practice determined that a clinical faculty member and former professor in the Department of Psychiatry was responsible for the deaths and injuries of 46 separate patients under his care. Five committed suicide. Seventeen were research subjects enrolled in clinical studies.

We have been trying to get answers to the questions posed by Gov. Carlson since October 2013, when bioethics professor Carl Elliott filed an open-records request for selected reports of deaths and serious injuries in psychiatric studies at the U. Six months later, he has received reports of only three of the 54 studies identified. This information is not supposed to be secret.

Flowers and a coffin

On May 9, a group of students, faculty members and concerned community members held a vigil in remembrance of Dan Markingson outside the McNamara Alumni Center, where the Board of Regents was meeting. We then interrupted the Regents’ meeting and presented them with flowers in Markingson’s honor. Four students wearing white coats carried a coffin to the door of the meeting room, where they were stopped by campus security guards.

Later, in public comments, Leigh Turner, an associate professor of bioethics at the U, asked the Regents, “Why are open-records requests to obtain such data (about deaths and injuries) routinely stonewalled? Are you ready for the possibility of multiple lawsuits brought by victims of psychiatric research misconduct?”

It is astonishing that it has come to this. The actions of the university have drawn international condemnation. Hundreds of medical experts have called for an independent investigation of Markingson’s death, including three former editors of the New England Journal of Medicine. Evidence of abuse has steadily accumulated. Michael Carome, the former deputy director of the federal Office of Human Research Protection, says that this latest case is so troubling it deserves a federal investigation.

Does it really take a coffin and funeral flowers to get the attention of the Board of Regents?

Eden Almasude is a medical student at the University of Minnesota. Matthew Boynton writes on behalf of Students for a Democratic Society at the U of M. Carl Elliott is a professor at the Center for Bioethics at the U; Leigh Turner is an associate professor at the Center for Bioethics.